ACTRN12624001185550尚未招募Unknown
Pancreatic, nutritional and clinical outcomes in children 0-5 years with cystic fibrosis during the first 2 years of CFTR modulator therapy (PaNC): a multicentre prospective observational study.
Caitlin Miles (Chief Investigator/Coordinator), Monash Health0 个研究点目标入组 160 人开始时间: 2024年9月27日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- Growth (composite outcome)[Weight (kg) - infant scale or standing scale <br>Length/height (cm) - infant length scale or stadiometer <br>Weight-for-length and BMI (kg/m2) and corresponding z scores and percentiles - calculated using online tool 'PediTools' Baseline (prior to commencing ETI/IVA therapy)<br>Every 3 months for the first two years of ETI/IVA therapy <br>2 years post commencement of ETI/IVA therapy ];Nutritional biomarkers (composite outcome) [Serum levels of vitamin A, D, E, B12, holoTC, ferritin, INR and CRP. Baseline (prior to commencing ETI/IVA therapy)<br>1 months post commencement of ETI/IVA therapy <br>2 years post commencement of ETI/IVA therapy ]
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 4 Months 至 5 Years（—）
- 性别
- All
入选标准
- •Infants and children 4 months - 5 years of age with a confirmed diagnosis of CF (as diagnosed by standard criteria; sweat test greater than or equal to 60mEq/L and/or CFTR gene mutation analysis) who are eligible for the commencement of ETI or IVA. Infants and children will be eligible for the study regardless of their respiratory health or presence of comorbidities.
排除标准
- •Infants and children older than 5 years of age with a confirmed diagnosis of CF or infants and children 4 months - 5 years of age who are not eligible for the commencement of ETI or IVA.
结局指标
主要结局
Growth (composite outcome)[Weight (kg) - infant scale or standing scale <br>Length/height (cm) - infant length scale or stadiometer <br>Weight-for-length and BMI (kg/m2) and corresponding z scores and percentiles - calculated using online tool 'PediTools' Baseline (prior to commencing ETI/IVA therapy)<br>Every 3 months for the first two years of ETI/IVA therapy <br>2 years post commencement of ETI/IVA therapy ];Nutritional biomarkers (composite outcome) [Serum levels of vitamin A, D, E, B12, holoTC, ferritin, INR and CRP. Baseline (prior to commencing ETI/IVA therapy)<br>1 months post commencement of ETI/IVA therapy <br>2 years post commencement of ETI/IVA therapy ]
次要结局
未报告次要终点
研究者
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